Drugs

FDA Touts Alternative Inspection Oversight Results

FDA acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Janet McMeekin say the agency has used alternative oversight tools when the pandemic prevented investigators from entering facilities for inspections. Writing in an FDA Voice post, the two say the agency prioritized “mission-critical” inspections on a case-by-case basis. When an in-person inspection was not possible, they say, FDA used:

compliance history reviews of facilities, including recalls and product complaints, to assist with prioritization;
leveraging information shared by trusted state, local, and foreign regulatory partners through mutual recognition and confidentiality agreements;
remote assessments for individual program areas to evaluate facility records;
review of records and information requests to facilities in advance or instead of drug and biological product inspections, and/or to support regulatory decisions and actions;
sampling and analytical testing of FDA-regulated products domestically and at the border; and
refusing entry of unsafe products into the U.S.

Woodcock and McMeekin say FDA continues to assess its efforts to execute regulatory oversight. Some of the results highlights they cite are:

taking on-time actions to evaluate and close-out new and generic drug applications more than 90% of the time, meeting review program performance commitments;
refusing more than $1.2 million worth of filtering faceplate respirators to prevent the proliferation of ineffective respirators used by healthcare workers;
placing dangerous and sub potent hand sanitizers on import alert;
· conducting a mix of mission-critical onsite inspections and remote record reviews to help ensure product approvals/authorizations were not delayed;
using several tools to ensure that medical devices continue to meet requirements for safety and effectiveness.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome